Masimo Corporation Release: New Clinical Study Presented At The American Society of Anesthesiologists Annual Meeting Shows Benefit Of Oxygen Reserve Index(TM), ORI(TM)

IRVINE, CA--(Marketwired - October 15, 2014) -

Masimo (NASDAQ: MASI) announced today that a new clinical study evaluating Masimo’s latest noninvasive patient monitoring parameter, Oxygen Reserve Index ORI, showed that ORI can provide advanced warning of potential hypoxia and may help clinicians optimize oxygenation before and during prolonged intubation.(1)

The study was among 12 selected from more than 1,000 as one of the Best Abstracts at the American Society of Anesthesiologists (ASA) Annual Meeting in New Orleans, the largest gathering of anesthesiologists in the world.

At the University of Texas Southwestern and Children’s Medical Center in Dallas, Dr. Peter Szmuk et al., used ORI to track oxygen available in the lungs during pre-oxygenation, safe apnea, and re-oxygenation. Investigators noted, “Since pre-oxygenation can cause oxygen saturation at 100% for variable durations, this study would aid in the development of an advance indication of desaturation."(1)

Pulse oximetry (SpO2) provides noninvasive and continuous visibility to arterial blood oxygenation in hypoxia (less than normal oxygenation) and normoxia (normal oxygenation). During supplemental oxygen administration, clinicians often use the partial pressure of oxygen (PaO2), which is intermittent and delayed, to monitor levels of hyperoxia (higher than normal oxygenation). Between invasive sampling, changes in PaO2 cannot be assessed and therefore unexpected hypoxia or unintended hyperoxia can occur.

ORI, Masimo’s 11th rainbow® parameter(2), provides real-time visibility to oxygenation status in moderate hyperoxic range (PaO2 of approximately 100 to 200mmHg). ORI is intended to supplement, not replace, SpO2 monitoring and PaO2 measurements. As an “index” parameter with a unit-less scale between 0.00 and 1.00, ORI can be trended and has optional alarms to notify clinicians of changes in a patient’s oxygen reserve.

With IRB and parental consent, researchers included for analysis 17 pediatric patients scheduled for surgery under general anesthesia with orotracheal intubation.

Optical data was collected using a Masimo Radical-7® Pulse CO-Oximeter, recorded from the time of sensor placement until five minutes after ventilation was restarted after intubation.

The mean time (+/-SD) from the start of the ORI alarm to SpO2 98% was 40+/-52 seconds. During re-oxygenation, the time from SpO2 98% to stop of the ORI alarm was 65+/-31 seconds.

“An advanced predictor of desaturation would be of great benefit to perioperative monitoring,” researchers said. “The ORI alarm provides an increased warning time for avoiding potential hypoxia and could help in optimizing the oxygenation before and during prolonged intubation.”

“Masimo congratulates Dr. Szmuk and his colleagues for the achievement and recognition they received at ASA this year,” said Masimo founder and CEO Joe Kiani. “Their evaluation of ORI lays the groundwork for other clinicians to utilize this useful noninvasive parameter, designed to improve clinical decision-making and patient outcomes.”

Radical-7® with ROOT has a CE Mark with the ORI parameter and is not FDA cleared and is not available for sale in the United States.

1. Szmuk P, Steiner J, Olomu P, Dela Curuz J, Sessler D. Oxygen Reserve Index - a New, Noninvasive Method of Oxygen Reserve Measurement” Proceedings of the American Society of Anesthesiologists, Oct.14, 2014, New Orleans, BOC12, Room 275-277
2. 11 parameters include: 1) oxygen saturation (SpO2); 2) Pulse rate; 3) Perfusion index (PI); 4) Pleth Variability Index (PVI); 5) Respiration Rate from the pleth (RRp); 6) Total hemoglobin (SpHb); 7) Oxygen Content (SpOC); 8) Carboxyhemoglobin (SpCO); 9) Methemoglobin (SpMet); 10) Fractional oxygen saturation (SpfO2); 11) Oxygen Reserve Index (ORI)

About Masimo
Masimo (NASDAQ: MASI) is the global leader in innovative noninvasive monitoring technologies that significantly improve patient care -- helping solve “unsolvable” problems. In 1995, the company debuted Measure-Through Motion and Low Perfusion pulse oximetry, known as Masimo SET®, which virtually eliminated false alarms and increased pulse oximetry’s ability to help clinicians detect life-threatening events. More than 100 independent and objective studies have shown that Masimo SET® outperforms other pulse oximetry technologies, even under the most challenging clinical conditions, including patient motion and low peripheral perfusion. In 2005, Masimo introduced rainbow ® Pulse CO-Oximetry™ technology, allowing noninvasive and continuous monitoring of blood constituents that previously required invasive procedures; total hemoglobin (SpHb®), oxygen content (SpOC™), carboxyhemoglobin (SpCO®), methemoglobin (SpMet®), PVI®, and perfusion index (PI), in addition to measure-through motion SpO2, and pulse rate. In 2008, Masimo introduced Patient SafetyNet™, a remote monitoring and wireless clinician notification system designed to help hospitals avoid preventable deaths and injuries associated with failure to rescue events. In 2009, Masimo introduced rainbow® Acoustic Monitoring™, the first-ever commercially available noninvasive and continuous monitoring of acoustic respiration rate (RRa™). Masimo SET® and Masimo rainbow® technologies also can be found in over 100 multiparameter patient monitors from over 50 medical device manufacturers around the world. Founded in 1989, Masimo has the mission of “Improving Patient Outcome and Reducing Cost of Care... by Taking Noninvasive Monitoring to New Sites and Applications®.” Additional information about Masimo and its products may be found at www.masimo.com.

Forward-Looking Statements
This press release includes forward-looking statements as defined in Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, in connection with the Private Securities Litigation Reform Act of 1995. These forward-looking statements are based on current expectations about future events affecting us and are subject to risks and uncertainties, all of which are difficult to predict and many of which are beyond our control and could cause our actual results to differ materially and adversely from those expressed in our forward-looking statements as a result of various risk factors, including risks related to our assumptions regarding the repeatability of clinical results, risks related to our assumptions that Masimo ORI offers noninvasive, continuous patient monitoring enabling full-time visibility to dissolved arterial oxygen status that may enable proactive interventions in all patients, as well as other factors discussed in the “Risk Factors” section of our most recent reports filed with the Securities and Exchange Commission (“SEC”), which may be obtained for free at the SEC’s website at www.sec.gov. Although we believe that the expectations reflected in our forward-looking statements are reasonable, we do not know whether our expectations will prove correct. All forward-looking statements included in this press release are expressly qualified in their entirety by the foregoing cautionary statements.

Masimo, SET, Signal Extraction Technology, Improving Patient Outcome and Reducing Cost of Care... by Taking Noninvasive Monitoring to New Sites and Applications, rainbow, SpHb, SpOC, SpCO, SpMet, PVI are trademarks or registered trademarks of Masimo Corporation.